Monday, January 26, 2009

Byetta health risks and concerns.


Eli Lilly & Co. and Amylin Pharmaceuticals, Inc. notified the FDA about four more deaths from pancreatitis among users of their diabetes drug Byetta. These four cases are in addition to two other Byetta pancreatitis deaths the FDA cited in their notice to healthcare providers last week. Byetta is an injection given twice a day to patients with Type-2 diabetes to lower their blood sugar levels. Concerns have grown recently among users and prescribers about the life threatening side effect.

On August 18, 2008, the FDA posted an alert on their website to notify doctors that the agency had received reports of at least six cases of necrotizing pancreatitis or hemorrhagic pancreatitis associated with Byetta. The FDA indicated that two of those six had died as a result of the severe cases of acute pancreatitis, and the other four were recovering. Despite this data, Eli Lily and Amylin do not believe there is any definite relationship between the drug and the deaths. The manufacturers and the FDA are in talks now for giving Byetta a "black box" warning for the risks of pancreatitis.

The first known Byetta pancreatitis lawsuit has already been filed in San Diego Superior Court on August 20, 2008. The diabetic patient was hospitalized back in December of 2007 with pancreatitis after using Byetta. The Byetta lawsuit alleges that Amylin and Eli Lily failed to test and monitor the side effects of the drug and did not issue warnings on the label about the potentially life threatening condition of pancreatitis.

Fentanyl Patches could cause you to overdose.


The Johnson & Johnson Corporation voluntarily recalled 32 million of their Fentanyl Patches on February 12 th , 2008 . Of these 32 million, an estimated 2 million of the Fentanyl Patches could possibly have a defect that can lead to an accidental overdose. The Duragesic Pain patch, which is sold by PriCara and the Fentanyl Transdermal System Patch, sold by Sandoz were involved in this Pain Patch Recall.

This Fentanyl Patch Recall involves all 25-microgram-per-hour patches that are sold in the U.S. by J&J's PriCara unit and Sandoz; made by another J&J unit, Alza Corp. All of the patches affected in the recall are only sold in the United States and they all have expiration dates set on or before December of 2009.

The defect that has caused this recall is a possible cut along one side of the drug reservoir within the patch. If the fentanyl patch does have a cut in it the fentanyl gel within can leak into the pouch the patch is packaged in and easily be transferred to the patient or caregiver when opened. Direct exposure to fentanyl gel can cause serious harm, including an accidental overdose. Anyone who believes they may have a damaged fentanyl patch should immediately properly dispose of the patch to eliminate the risk of accidental overdose.

Pain Pumps may be more painful than you thought.


Intraarticluar Pain Pumps are often used after shoulder surgery to help aid in pain management. These pumps are implanted in the shoulder joint and are used to dispense pain medication. These pumps were believed to be a better way to manage pain after surgery, but recently it has been found that this may be incorrect and the Intraarticular Pain Pumps could be doing more damage than good.

In 2006, the American Academy of Orthopedic Surgeons studied the medical charts of 152 patients who had arthroscopic surgeries. Of these 152 patients, 12 were found to have a condition known as Postarthroscopic glenohumeral chondrolysis or PAGCL. A study was also published by the American Journal of Sports Medicine in July stating that these pain pumps were a likely cause of PAGCL. This condition causes increased pain and stiffness in the shoulder, constant need for pain management, reduced strength, a limited range of motion and a probable need for continual pain management. Patients who suffer from PAGCL also need to undergo more surgery, and there is a chance that the injured shoulder will never fully recover.

Asthama Episodes and or Possible death using Serevent.

According to the FDA, some patients using Serevent might face life-threatening asthma episodes and possible death. Although FDA officials emphasize that problems from Serevent happened rarely, many people have suffered from serious side effects. If you or someone you love has been suffering from side effects caused by Serevent, then we urge you to contact a Serevent Inhaler lawyer or a Serevent Inhaler attorney. If you are suffering, you deserve justice. Complete the form below to find Serevent Inhaler Law Firms in your immediate area.

The medicine in Serevent Inhaler is known as a bronchodilator. It works by relaxing muscles in the airways to improve breathing and relieves the symptoms of asthma and other chest conditions. Serevent inhalation is mainly used to treat asthma. Serevent is not used to treat an attack already in progress but for the prevention of asthma attacks. It will not work fast enough to give relief during an attack. In a study, 36 patients taking Serevent died from asthma or had life-threatening attacks. Some patients taking Serevent have had trouble breathing and required intubations, the insertion of a tube into the throat forcing open the airways.

Serevent, Advair, and Seretide asthma medications are under close scrutiny by FDA. The active ingredient it contains seems to be capable of actually causing asthma attacks in some instances. Clinical trials demonstrated an increased rate of asthma-related deaths, according to FDA, by a factor ranging from three to eight times greater than patients receiving no medication. Patients' asthma may have progressed and worsened rather than being controlled effectively. The risks may be greater for non-Caucasian patients.

Cipro has been Black Boxed!


Cipro was issued a Black Box warning by the FDA on July 8th, 2008 due to concerns of tendonitis and tendon ruptures. Cipro is manufactured by Bayer HealthCare and is an antibiotic and used in adults as a lung, sinus, skin and urinary tract infection treatment. Cipro (ciprofloxacin) is in a class of antibiotics called fluroquinolone, which are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

The FDA has recently conducted a new analysis of the available literature and post-marketing adverse event reports for Cipro and found that its use is associated with an increased risk of tendon rupture and, despite the current warning of tendon rupturing in the labeling large numbers of adverse events continue to be reported. It has been discovered that the risk of tendonitis or tendon rupture is higher in patients over the age of 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients.

The FDA states that pain, swelling, inflammation, and tears of tendons including the Achilles, shoulder, hand, or other tendons can happen in patients taking fluoroquinolone antibiotics such as Cipro. Pain, swelling or inflammation in a tendon area could be symptoms of tendonitis or tendon rupture, as well as, a snap or pop in a tendon area, bruising right after an injury in a tendon area and inability to move the affected area or bare weight.

If you use Advair Diskus and are experiencing asthma symptons please read.


Over the past few years the FDA has sent out more than one Public Health Alert on the Advair Diskus, manufactured by GlaxoSmithKline. Advair, used for treatment of asthma and chronic obstructive pulmonary disease (COPD), has been linked with worsening asthma symptoms and increased risk of asthma-related death.


On November 18, 2005, FDA alerted health care professionals and patients that Advair had been associated with possible increased risk of worsening wheezing (bronchospasm) in some people, and requested that manufacturers update warnings in their existing product labeling. This information has now been included in updated labeling.

The most recent update, on March 5, 2008 stated: On November 28, 2007, a Pediatric Advisory Committee (PAC) meeting was held. At this meeting, FDA raised concerns about the safety of long-acting beta2 adrenergic agonists (LABAs) in pediatric patients with asthma. The PAC has agreed with an FDA recommendation to continue assessment of the risks of LABAs and seek advice from a future advisory committee.

In January, 2008 FDA requested manufacturers of Advair Diskus and Advair HFA to provide information regarding controlled clinical studies conducted with these products in order to further evaluate the safety of LABAs when treating asthma.

The manufacturers have indicated it will take several months to submit the requested information. Following review of this information, FDA plans to bring the issue of the benefit/risk assessment of LABAs in adults and children to an advisory committee in the fall or winter of 2008.

Melamine Contamination

In September of 2008 the FDA became aware of thousands of infant illnesses in China associated with the consumption of infant formula suspected of containing Melamine. Melamine is a compound used primarily in commercial and industrial applications. There is no approved melamine use in direct addition to human or animal food in the U.S.

As recently as October 1st, 2008 reports indicated there have been over 53,000 illnesses, nearly 13,000 hospitalizations, 100 seriously ill cases and at least four infant deaths in China. It has also been reported that a number of infants in China who have consumed Chinese manufactured infant formula are suffering from kidney stones, a condition which is rare in infants.

As a result, the U.S. and other countries have been sampling and testing infant formula, milk-derived ingredients, and finished food products containing milk. Information received from a number of sources, and from a number of different countries, indicates a wide range and a variety of products, such as candies, desserts and beverages have been found to be contaminated with melamine.

On September 12th, 2008 the FDA is advised caregivers not to feed infant formula manufactured in China to infants. This should be replaced with an appropriate infant formula manufactured in the United States. Individuals should contact their health care professional if they have questions regarding their infant's health or if they note changes in their infant's health status.

To date, FDA testing has found melamine contamination in multiple products imported from China. FDA is continuing its testing of a variety of products for melamine and has advised consumers not to consume the following products because of possible melamine contamination:

  • Topaz Wafer Rolls with Chocolate Flavored Cream Filling
  • Topaz Wafer Rolls with Hazelnut Chocolate Flavored Cream Filling
  • Topaz Wafer Rolls with Vanilla Flavored Cream Filling
  • Topaz Wafer Rolls with Mocha Cappuccino Flavored Cream Filling
  • G&J Hot Cocoa Stuffer Item 120144
  • G&J His and Hers Hot Cocoa Set Item 120129
  • Wonderfarm "Successful" Assorted Biscuits
  • Wonderfarm "Royal Flavour" Assorted Biscuits
  • Wonderfarm "Lovely Melody" Assorted Biscuits
  • Wonderfarm "Daily Life" Assorted Biscuits
  • Topaz Hazelnut Wafer Rolls with Hazelnut Chocolate Flavored Creme Filling
  • Sweet Time Christmas Dressy Bear with Chocolate Bar
  • Fresh and Crispy Jacobina Biscuits
  • Koala's March Creme filled Cookies
  • YILI Brand Sour Milk Drink
  • YILI Brand Pure Milk Drink
  • Blue Cat Flavored Drinks
  • White Rabbit Candies
  • Mr. Brown Mandehling Blend Instant Coffee (3-in-1)
  • Mr. Brown Arabica Instant Coffee (3-in-1)
  • Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
  • Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
  • Mr. Brown French Vanilla Instant Coffee (3-in-1)
  • Mr. Brown Mandheling Blend instant Coffee (2-in-1)
  • Mr. Brown Milk Tea (3-in-1)
  • Infant formula manufactured in China
  • G&J Cocoa item 120126, sold in 2 flavors: French Vanilla Cocoa and Double Chocolate Cocoa